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This is a multi-center, phase I, open clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of TWP-102 injection in patients with advanced malignancies. This study consists of two parts, including a dose escalation study and a dose expansion study. The criteria for dose escalation will be based on the Bayesian optimal interval (BOIN) design with sequentially enrolled cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Cohort | Experimental | Four dose levels of TWP-102 injection will be tested by BOIN study design. |
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| Dose Expansion Cohort | Experimental | Once the effective doses have been determined, two expansion cohorts will be opened to evaluate the efficacy and safety in one or two tumors. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TWP-102 injection | Drug | IV infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events/serious adverse event related with TWP-102 injection | From enrollment until 90 days after the last dose | |
| Dose-limiting toxicity (DLT) | From the first dose of study drug up to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum measured plasma concentration (Cmax) of TWP-102 injection. | From first dose until 90 days after the last dose | |
| Time to maximum plasma concentration (Tmax) of TWP-102 injection. | From first dose until 90 days after the last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shengbin Ren | Contact | 8021-60167707 | shengbin.ren@therawisdom.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | 150001 | China |
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| Half-life (T1/2) of TWP-102 injection. | From first dose until 90 days after the last dose |
| Immunogenicity profile of TWP-102 injection. | Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies. | From first dose until 90 days after the last dose |
| Objective Response Rate (ORR) | From first dose to disease progression or end of study, an average of 2 years |
| Duration of Response (DOR) | From first dose to disease progression or end of study, an average of 2 years |
| Disease control rate (DCR) | From first dose to disease progression or end of study, an average of 2 years |
| Progression free survival (PFS) | From first dose to disease progression or end of study, an average of 2 years |